Direct Oral Anticoagulants: Best Safety Practicesapp.ihi.org/FacultyDocuments/Events/Event-2930/Presentation-16026/... · Transitions Coordinator, Emergency Department ... Direct

Direct Oral Anticoagulants: Leading Safety Practices

Ellyn Flynn, RN, MBA, JD, CPPSAVP Safety Program, Vizient

Jessica Schoenthal, RN, MSN, CPPSCollaborative Advisor, Vizient

Steven Meisel, Pharm.D., CPPSSystem Director of Medication Safety, Fairview Health Services/Healtheast Care System

Session Code C30

The presenters have

nothing to disclose

December 12, 20171:30 PM- 2:45 PM

#IHIFORUM

Session objectives

• Identify transition of care contributing factors of direct oral

anticoagulant (DOAC) safety events.

• Implement leading practices to improve the reliability of

inpatient and outpatient DOAC management.

• Identify ways to include patients and families in their DOAC

safety plan.

© 2017, Vizient PSO and Vizient Data Services, LLC. Do not distribute outside of your institution without permission from Vizient. Disclaimer: For

informational purposes only and does not, itself, constitute medical advice. This does not replace careful medical judgments by qualified medical personnel. There may be information that does not apply to or may be inappropriate for the medical situation. 2

Presenter disclosures

• The speakers have no financial disclosures.

• The opinions expressed in this presentation do not reflect

the official position of the Agency for Healthcare Research

and Quality (AHRQ).

• This information is not being offered as legal or medical

advice.

3


informational purposes only and does not, itself, constitute medical advice. This does not replace careful medical judgments by qualified medical

personnel. There may be information that does not apply to or may be inappropriate for the medical situation.

Vizient™ Patient Safety Organization

4

Vizient Patient Safety Organization

• The Vizient Patient Safety Organization (formerly the University Health

System Consortium Safety Intelligence PSO) became federally-listed

by AHRQ in 2008

• Certified through 2020

• National participation across 34 states and over 260 providers

• AHRQ Common Formats (v.1.1 and 1.2) integrated with its proprietary

taxonomy

• Meaningful comparison data

• National leadership role in PSO activities

• Regular NPSD submissions via PSOPPC

5

NPSD = Network of Patient Safety Database

PSOPPC = Patient Safety Privacy Protection Center




Patient Safety Organizations

PSOs collect and analyze data in a standardized manner using the AHRQ Common

Formats, identify safety improvement opportunities and share learnings widely.

Events reported and

reviewed

Risks and hazards

identified

Learnings accelerated

Prevention strategies identified

Learnings shared

Harm Reduced




6

Other

• Privilege and

confidentiality protection

for PSWP

• Multidimensional

Analytic Tool access

• Annual evidence-based

feedback report with

comparative data

• Access to Vizient

Performance

Management resources

• PSO manager

consultation and

coaching via telephone

and email

Vizient PSO - Offering Details

Participation in the Vizient PSO provides:

Educational

opportunities

• Safety alerts,

checklists and white

papers

• Evidence based and

expert consensus

recommendations

• Patient Safety

Evaluation System

(PSES) documentation

calls

• PSO operations

orientation

• Patient safety officer

education

• Case law updates

7

Additional services

(incremental fee)

• PSES documentation

support

• NPSD reporting

• Quarterly feedback report




Collaboration

opportunities

• Safe Table

participation

(minimum of six per

year)

• Safety huddles

(bimonthly)

• Leading practice

development projects

• 2 in-person PSO

conferences

• Quarterly virtual PSO

user group

• PSO listserv

participation

Expert Medication Safety Advisory Team

8

Jessica Schoenthal, RN, MSN, CPPS

Collaborative Advisor

Vizient PSO

9

• Medication safety

• Anticoagulants

• Opioid overdose (pain

management)

• Sedation/Anesthesia

management

• New concentrated insulins

(hypoglycemia)

• Falls

• Cardiac alarm monitoring

• Behavioral management

• Suicide

• Violence

• Delays in diagnosis

• Stroke

• Surgical complications

associated with patient

optimization

• Critical result reporting delays

• Cardiac or respiratory arrest

outside of critical care

Summary of event types resulting in high harm

Vizient PSO Data from 2014-June 2017




Advisory team roles

Team members

• Attend and participate in meetings

• Share knowledge and learnings

• Define project topic

• Define objectives and deliverables

• Share leading practices

• Provide feedback on toolkit

• Participate in safe table meetings

and/or webinar

PSO Collaborative advisors

• Organize and facilitate meetings

• Analyze data

• Assemble member learnings and

leading practices, results of data

analysis and evidence-based

recommendations

• Communicate materials collected to

the advisory team

• Draft and publish toolkit

• Facilitate webinars

Time commitment: Approximately 4-6 hours per participant over four months

10




Benefits of advisory team collaboration

• Blends complementary perspectives to achieve best outcome.

• Accelerates learning from many organizations.

• Accomplishes more than individuals can do alone.

• Provides everyone an opportunity to teach and learn.



personnel. There may be information that does not apply to or may be inappropriate for the medical situation. 11

Medication Safety Advisory Team Members

Name Credentials Title Organization

Vanessa B. Bibbs BSN Accreditation Nurse Specialist Vidant Health

Luba BurmanPharm.D., BCPS,

CDEClinical Assistant Professor, Pharmacy Practice

Chicago State University-

College of Pharmacy

John W. Cromwell MD, FACS,

FASCRS

Associate Chief Medical Officer, Director of Surgical

Quality and Safety; Director, Division of

Gastrointestinal, Minimally Invasive and Bariatric

Surgery Clinical Professor,

University of Iowa Hospitals &

Clinics; University of Iowa

Carver College of Medicine;

Robert M. Dean DO, MBA Senior Vice President, Performance Management Vizient

Tejaswini More

DhawaleMD

Assistant Professor, Division of Hematology

Scholar, Attending Physician,

Platinum/Immunotherapy Service

Center for scholarship in patient

care quality and safety; UWMC

Cheryl EdwardsBS Pharm,

Pharm.D., MBAMedication Safety Manager Parkland Health and Hospital

Ellen FlynnRN, MBA, JD,

CPPSAVP Safety Program Vizient

Rachel Hensley Pharm.D., MBA Directory of Pharmacy SSM Health

Timothy Lesar Pharm.D.Director of Clinical Pharmacy Services, Patient care

Services DirectorAlbany Medical Center

Jim LichauerPharm.D., BCPS,

FASHP

Project Manager, PI Collaborative and Advisory-

Pharmacy Vizient

12






Elena Meeker Pharm.D., BCPS Medication Safety PharmacistUniversity of Washington

Medical Center

Steven B. Meisel Pharm.D., CPPS Director of Patient Safety Fairview Health Services

Joe Melucci RPH, MBA, Medication Safety OfficerThe Ohio State University

Wexner Medical Center

Scott Murray Pharm.D.

Senior Pharmacist, Medication Safety and Pharmacy

Transitions Coordinator, Emergency Department

Pharmacy Manager

Upstate University Hospital

Ketan Patell Pharm.D. DHS-Pharmacy Affairs LA County

Christi Quarles Smith Pharm.D., MBA Assistant director Pharmacy for medication safety University of Arkansas

Jessica Schoenthal RN, MSN, CPPS Collaborative Advisor Vizient Inc.

Robert Sikorski MD

Assistant Professor, Medical Director of Trauma

Anesthesiology, Department of Anesthesiology and

Critical Care Medicine

The Johns Hopkins Hospital

Michelle Then Pharm.D., MBAPharmacy Manager, Medication Safety, Quality &

Regulatory, Denver Health

Syeda WasimaPharm.D.,/MPH

Student PSO Intern Vizient Inc.

Tammy Williams RN, MSN, CPPS Collaborative Advisor Vizient Inc.

13




Overview of the medication safety project

Feb 2017

Advisory team identified DOACs as the highest priority

Feb 2017

PSO analyzed data,

researched literature, and

collected leading

practices

March 2017

PSO conducted DOAC safe

table meeting and reviewed findings with

advisory team

April 2017

PSO facilitated

team review and revision of safety alerts and leading

practices

June -October

2017

PSO distributed

Safety Alerts and shared

learnings in a topical

webinar

14

Share learnings

Create deliverables

Identify solutions

Define project and deliverables




Advisory team’s top safety concern

dabigatran apixaban

Eliquis™ rivaroxaban

XARELTO™ Pradaxa™

Savaysa™ edoxaban Lixiana™

15

Direct oral anticoagulants (DOAC)




Anticoagulants: High risk and problem prone

The Institute for Safe Medication Practices reported that harm from oral

anticoagulants ranks as one of the highest priority drug safety problems

in 2016 by several measures.

• In clinical trials, oral anticoagulants repeatedly demonstrated high

injury rates, causing bleeding in 8% to 19% of patients treated for a

year.

• Anticoagulants are used by a large and growing population, notably

the elderly.

• Reports of serious injuries and death are also featured prominently in

the 2016 U.S. Food and Drug Administration (FDA) Adverse Event

Reporting System data

− Serious injuries (n=18,978) and deaths (n=3,018) in the US

16




http://www.ismp.org/newsletters/acutecare/showarticle.aspx?id=1172. Accessed 11/24/2017

http://www.ismp.org/newsletters/acutecare/showarticle.aspx?id=1172

Warfarin versus DOAC




17

Advantages Disadvantages

Warf

ari

n

• Broad indications for use

• Allows adherence to be monitored

• Recognized by practitioners as an

anticoagulant

• Long half-life

• Slower onset/offset of action

• Food-drug interactions

• Drug-drug interactions

• Routine monitoring required with

associated costs

DO

AC

• Fixed dosing

• Less monitoring

• Direct mechanism of action with

rapid onset

• Fewer food and direct drug

interactions

• Improved patient satisfaction and

quality of life

• Narrow indications for use

• Not readily recognized as

anticoagulants

• Reversal protocols and antidotes

under development

• Dose adjustment required for impaired

renal function

• Limited availability of assays for

measuring drug levels

• Absence of validated monitoring

strategies. to evaluate compliance

• Higher cost to patientBurnett, A. E., Mahan, C. E., Vazquez, S. R., Oertel, L. B., Garcia, D. A., & Ansell, J. (2016). Guidance for the practical management of the direct oral anticoagulants (DOACs)

in VTE treatment. Journal of Thrombosis and Thrombolysis, 41, 206–232. http://doi.org/10.1007/s11239-015-1310-7

Bauer, Kennetha A. (2013). Pros and cons of new oral anticoagulants. American Society of Hematology . 446-470

http://doi.org/10.1007/s11239-015-1310-7

Analysis of PSO event reports involving DOACs

18

DOAC event report data

A retrospective review of 273 voluntary PSO reports

identified opportunities to improve care for DOAC patients.

Text search for generic and brand names for the following drugs:

• Rivaroxaban (Xarelto™)

• Apixaban (Eliquis™)

• Dabigatran (Pradaxa™, Prazaxa™)

• Edoxaban (Savaysa™, Lixiana™)

19




Harm scores assigned in DOAC events

20

Period of data: January 2014- July 2017; Number of events= 273

AHRQ Common Format Harm Scale v.11




72% of all DOAC events reported reached the patient

36% of reported DOAC events resulted in harm (emotional distress to death).

Communication breakdowns

21




Period of data: January 2014- July 2017

Number of events = 273

Medication-related event subcategories

22




Period of data: January 2014- July 2017; Number of DOAC events = 273

Number of DOAC events categorized as medication-related event type = 175

DOAC wrong dose event types

23

Patients received an

overdose or extra dose

of anticoagulation in

nearly 60% of DOAC

medication wrong dose

events voluntarily

reported to the PSO.




Period of data: January 2014- July 2017

Number of wrong dose events = 39

Opportunities identified in PSO data and safe table discussion

• Decreasing occurrence of unintentional duplicate therapies in

anticoagulation

• Individualization of standardized care

• Improving transitions of care - medication reconciliation

• Effective patient and family education

• Selection of the best drug for the patient - indication, age, renal

function or drug interactions

• Development of adequate reversal strategies and policies

• Constancy of anticoagulation peri-operative management

• Creation of order sets to eliminate dosing errors

• Reliably dosing morbidly obese patients

24




High harm event overview

DOAC high harm events were associated with acute bleeding

• GI bleeding

• Epistaxis

• Hematomas

• Intracranial hemorrhage

Common contributing factors in high harm DOAC events

• Therapeutic duplication (35%)

• Inappropriate dose for clinical condition (35%)

• Breakdown in discharge instructions and lack of patient teach back

(10%)

25




DOAC case scenarios

26

Example 1

• A 64 year old man was admitted with a pulmonary embolism and a

history of recent spinal surgery.

• His provider ordered “hold anticoagulation” and completed a pre-

authorization request form for rivaroxaban therapy.

• The pharmacy dispensed rivaroxaban, despite the top of the form

stating: "This form is not a substitute for a prescription order.”

• This patient was placed at an increased risk for bleeding complications

after spinal surgery.

27




The case described is not an actual case study and does not contain actual patient level data. The case represents an issue or error that can or commonly occurs.

Example 2

• A 70 year old male was admitted to the hospital for evaluation of heart

valve disease.

• He takes dabigatran for atrial fibrillation at home, and initial evaluation

of laboratory values revealed that patient had a critically elevated INR.

• He had less than optimal renal function, and the dabigatran dose was

not adjusted accordingly.

• The dose prescribed was 150 mg twice daily, and it should have been

75 mg twice daily.

28





Example 3

• A 65 year old female was admitted after a fall and hip fracture. She

reported taking dabigatran twice a day at home for atrial fibrillation.

• Her last documented dose of dabigatran was the morning of

admission. The provider held dabigatran for 24 hours and then sent the

patient to the operating room for a hip repair.

• This organization’s perioperative anticoagulation guideline required

dabigatran to be held for at least 72 hours before surgery based on this

patient's renal function (CrCl less than 25).

• This patient experienced significant intraoperative bleeding, requiring

multiple blood transfusions and admission to a critical care unit

postoperatively.

29© 2017, Vizient PSO and Vizient Data Services, LLC. Do not distribute outside of your institution without permission from Vizient. Disclaimer: For




Example 4

• A 44 year old female was admitted as an inpatient and received

scheduled apixaban.

• On day three of admission, her physician ordered enoxaparin 1 mg/kg.

• The pharmacist verified and dispensed the enoxaparin.

• This patient received both apixaban and enoxaparin and experienced

bleeding from procedural site.

30





Example 5

• A 55 year old male who was hospitalized was on rivaroxaban, and

during the stay, his renal function deteriorated.

• His provider did not adjust or discontinue the rivaroxaban dose in

response to the decline in renal function.

• As a result, this patient experienced an upper GI bleed that resulted in

a cardiac arrest.





Patient-centered DOAC care coordination

32

Patient-centered DOAC care coordination

33

Patient

Initiation of therapy

Admission to acute

care

Discharge from acute

care

Peri-procedural

Ambulatory care




Safety alert: Discharge from acute care

34




Improving DOAC management for patients discharged from acute care

Implement a discharge checklist or timeout for patients prescribed

DOAC therapy.

• Reconcile manual (paper prescriptions) and electronic instructions at

discharge to identify therapeutic duplication and/or drug interaction.

• Verify that the patient has insurance approval for DOAC.

• Schedule a follow-up appointment with an anticoagulation clinic or

with a provider who can monitor therapy.

• Include importance of timely follow-up appointments during

discharge teaching.

• Ensure patient and/or their caregiver are able to teach back

medication plan.

• Call all DOAC patients within 24-48 hours of discharge.

Guidance for the practical management of the DOACs in VTE treatment available at

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4715848/




https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4715848/

36

Safety alert: Periprocedural




Improving periprocedural care coordination

• Convene a multidisciplinary team to define standard work for pre-,

intra- and post-op DOAC patients.i,ii

• Outline institutional policies and procedures, standardized order sets,

clinical pathways, and clinical decision support tools for management

of patients in urgent situations to avoid delays that could adversely

affect patient outcomes.iii

• Document the anticoagulant management plan and patient

concurrence in the patient’s medical record before undertaking the

procedure.

• Develop a process for individualization of standard work based on

patient risk factors (consider a team huddle with the patient).

37

iMichigan Anticoagulation Quality Improvement Initiative Anticoagulation Toolkit (V 1.7): A consortium-Developed Quick Reference for Anticoagulation.

http://anticoagulationtoolkit.org/sites/default/files/toolkit_pdfs/toolkitfull.pdfii UM Medicine Pharmacy Services (2014). http://depts.washington.edu/anticoag/home/content/uw-medicine-alternative-monitoring-antithrombotic-agents#apixabaniiiWilliam E. Dager, Pharm.D.., BCPS, MCCM, FCSHP, FCCM, FCCP, FASHP. Managing and Reversing Direct Oral Anticoagulants A Discussion Guide. American Society of

Health-System Pharmacists (ASHP). 2017.Available at: http://www.doacresources.org/faculty Accessed 8/24/17.




http://anticoagulationtoolkit.org/sites/default/files/toolkit_pdfs/toolkitfull.pdf

http://depts.washington.edu/anticoag/home/content/uw-medicine-alternative-monitoring-antithrombotic-agents#apixaban

http://www.doacresources.org/faculty

Improving DOAC quality and safety

• Share DOAC events, root cause analyses (RCAs) and failure mode

effects analyses (FMEAs) with your PSO to promote national learning.

• Raise awareness of DOAC utilization and safety events within your

organization.

- Safety alerts

- Case studies, safety stories and huddles

• Review DOAC related events with a multidisciplinary team.

- Identify contributing factors

- Review workflows

• Develop standard processes, guidelines and protocols for managing

DOAC therapy in all phases of care.

• Review Joint Commission standard MM.05.01.01 - pharmacy review.

38




One organization’s approach

Steve Meisel, Pharm.D., CPPS

Director of Patient Safety

Fairview Health Services

39

• Not-for-profit organization established in 1906

• Partner with the University of Minnesota since 1997

• 22,000+ employees

• 2,300 aligned physicians

• 7 hospitals and medical centers (1,602 staffed beds)

• 45+ primary care clinics

• 55+ specialty clinics

• 47 senior housing locations

• Home care, home medical and hospice

• Urgent care and retail clinics

2015 data

• 67,682 inpatient admissions

• 345,000 assigned/attributed lives

• $3.9 billion total revenue

Fairview Health Services Provides a full continuum of health and medical services.

2017: acquired Healtheast with its 4 hospitals and 12 clinics

40

Fairview Pharmacy Services

For consumers and patients

• Retail pharmacies (36)

• Hospital pharmacies (7)

• Specialty pharmacy (serves patients in all 50

states)

• Infusion services

• Medication therapy management (33 clinics)

• Mail service pharmacy

• Compounding pharmacy (IntegraDose©)

• Central packaging

• Long-term care/assisted living pharmacy

• Clinical trials services

• Anti-coagulation clinics (30)

• Wholesale pharmacy

• Center for Bleeding and Clotting Disorders

For employers and health

systems

• ClearScriptSM prescription

benefit management

• Fairview Purchasing

Network

• Excelera© Network

1,500+ FPS and inpatient pharmacy employees

2.5 million ambulatory prescriptions filled in 2015

$14 million in 1996 to over $1.1 billion in revenue

2016 data

• > 8,000,000 annual

inpatient doses dispensed

• 1.7 million annual retail

pharmacy prescriptions

41

Organizational approach to safety

42

Patient

safety

Leadership and

culture

Adaptive change:

resilience,

teamwork,

communication

Technical and

process: deploy all

known best practices

Innovation:

invent new best

practices

Measurement

Training

Organizational approach to safety

43

Designing reliable systems of care

44

Prevent

Detect

Mitigate

Prevent

• Order sets

• Computer alerts

• Double-checks

• Smart-pumps

• Hard stops

• Floor stock limits

• Pharmacist oversight

• Prospective risk

assessment

• Medication reconciliation

• Bar coding

45

Detect

• Computer alerts

• Double-checks

• Smart-pumps

• Monitoring devices and schedules

• Critical value management

46

TITLE & CONTENT

Mitigate

Protocols for recovery: prior to calling physician

• Narcotic oversedation

• Hypoglycemia

• Extravasation

• Rapid response teams

47

Basic tenet #1

Shame on us if we don’t learn from the experiences of others.

48

Basic tenet #2

If it has happened elsewhere, it can happen here. Complacency is an independent risk.

49

Basic tenet #3

If someone else has dreamed up a solution, we should implement it unless we can prove we can solve the problem better or differently.

50

Basic tenet #4

We will implement the same best practice universally across the company.

51

Basic tenet #5

If we have identified and/or solved a problem it is our obligation to share our experiences so others can benefit.

52

Errors with DOACs

53

Errors with DOACs: Harm

No reported A, F, G, H, or I events due to error. 4 ADEs

unrelated to error (one D & 4 F) also occurred during this time.

54

Error types

“Standard errors” (10)

• Missed dose or wrong time

• Omission (4)

• Failure of medication reconciliation (3)

• Wrong frequency ordered

• Capsule inappropriately opened

DOAC-specific errors (6)

• Overlap with heparin or aspirin (2)

• Renal dosing error (2)

• Transitions with heparin (2)

55

Case scenario 1

Patient had renal failure with estimated CrCl < 20 ml/min. Pharmacist

misunderstood the renal dose adjustment chart in the guideline table and

mistakenly adjusted the dose of apixaban down to 2.5mg bid (vs 5mg

bid). Two other pharmacists reviewed this chart over the next 4 days and

did not change the dose. (Harm D)

56

Case scenario 2

Patient was going for cardioversion. Cardiologist wanted apixaban

started before cardioversion. Med ordered at 0900, pharmacy verified at

0915 after discussing apixaban use while on heparin drip with him.

Heparin Xa came back about same time as all of this, and was sub-

therapeutic. Pharmacist ordered a heparin bolus and increased drip rate.

The pharmacist was approached after lunch by the nurse; she said she

did not see orders for apixaban and heparin bolus and rate change

because she had already released and "signed off on cardioversion

orders.“ (Harm D)

57

Case scenario 3

• Patient on Heparin protocol given 4,000 unit bolus late in the evening

subsequent to a low anti Xa level.

• Rivaroxaban 15mg orally daily with supper ordered at 22:46 and given at

00:36.

• 05:00 anti Xa level canceled, due to questionable specimen.

• Redraw of anti Xa level = 1.94 (critical); heparin discontinued

Problems

• Transition from IV heparin to rivaroxaban, which is supposed to start 2 hours

after heparin discontinuation. No orders to discontinue heparin.

• Due to recent IV bolus of heparin, rivaroxaban should have been delayed until

morning.

• The incorrect dose of rivaroxaban was prescribed. (should have been 15mg

PO BID for 21 days then decrease to 20mg PO daily. (Harm D)

58

Actions to prevent errors with DOACs

59

Order search

Choosing the tablet

Choosing the tablet

Transitions link

Provider resources link

Panel for initial dosing

Panel for initial dosing

Dabigatran “SIDE-PANEL” Wording

Dabigatran (Pradaxa) is an oral anticoagulant which works by directly

inhibiting thrombin.

DVT or PE Treatment/Prophylaxis Dose:

If CrCL is GREATER than 30 mL/min, give 150 mg PO BID.

Use dabigatran with caution in those > 75 years of age. (Consider reducing

dose to 110 mg if > 75 year old)

If CrCL is LESS than/equal to 30 mL/min, DO NOT USE.

Nonvalvular AFib Dose:

If CrCL is GREATER than 30 mL/min, give 150 mg PO BID.

If CrCl is 15-30 mL/min, give 75 mg PO BID.

If CrCL is LESS than 15 mL/min or if on dialysis, DO NOT USE.

Postoperative prophylaxis following hip replacement

If CrCl > 30 mL/min: Give 110 mg PO once, followed by 220 mg PO daily for

28-35 days.

If CrCL is LESS than/equal to 30 mL/min, DO NOT USE.

Guidance when transitioning FROM another anticoagulant over to Dabigatran

Converting

FROMInstructions for transitioning TO Dabigatran

Apixaban Give first dose of dabigatran when next apixaban dose would have been due.

Argatroban

BivalirudinStart dabigatran at the same time that argatroban/bivalirudin is stopped.

Edoxaban Wait 24 hours after last dose of edoxaban before starting dabigatran.

Enoxaparin

If taking high dose (1 mg/kg) enoxaparin: start dabigatran when NEXT dose of

enoxaparin would have been due.

If taking low dose (30-40mg daily) enoxaparin: start dabigatran whenever

clinically indicated, irrespective of when last enoxaparin dose given.

Heparin drip Start dabigatran at the same time that heparin drip is stopped.

WarfarinStop warfarin. Start dabigatran when the INR/chromogenic factor 10 is below

the therapeutic goal range.

Fondaparinux

If taking fondaparinux 5-10 mg daily, start dabigatran when NEXT fondaparinux

dose due. If taking fondaparinux 2.5 mg daily, start dabigatran whenever

clinically indicated (irrespective of when last fondaparinux dose given)

• Renal dosing protocols

• Medication reconciliation

• Anticoagulation clinics

– Discharged from clinic once INR <2 and on DOAC

– Considering quarterly visits

• Reversal protocols

• Required education for pharmacists

• Patient discharge teaching

– New starts (some hospitals)

• Interventional radiology hold protocol

Other actions

IR protocol

Anticoagulants Hold

apixaban (ELIQUIS) 24 HOURS

argatroban (ACOVA) NO HOLD

bivalirudin (ANGIOMAX) NO HOLD

dabigatran (PRADAXA) NO HOLD

edoxaban (SAVAYSA) 24 HOURS

enoxaparin (LOVENOX)

OUTPATIENT Minimal bleeding risk

Q12H and Q24H dosing: Hold enoxaparin dose the AM

of procedure

INPATIENT Minimal bleeding risk

Q12H and Q24H Dosing: Hold enoxaparin dose the AM

of procedure

fondaparinux (ARIXTRA) 24 HOURS

heparin

2 hour IV Heparin hold for the University and 4 hour IV

heparin hold for the community sites due to work flow

issues.

"SQ heparin Q8hrs -- hold for 8 hrs....

SQ heparin Q12 hrs-- hold for 12 hrs.... "

rivaroxaban (XARELTO) 24 HOURS

warfarin (COUMADIN)

Check with the interventional radiology department on

the hold time for the warfarin (COUMADIN).

The hold time length will be based on the INR of the

patient and the discretion of the provider based on the

level of the procedure risk.

IR protocolAnticoagulants HOLDapixaban (ELIQUIS) 48 hours

argatroban (ACOVA) 4 hours

bivalirudin (ANGIOMAX)

CRCL > 50 =

Hold 2 hours prior to procedure

CRCL< 50 =


dabigatran (PRADAXA)CRCL > 50 = Hold for 2 days

CRCL < 50 = Hold for 3 days

edoxaban (SAVAYSA) 24 hours


OUTPATIENT

Q12H dosing: Hold enoxaparin dose the night before AND

the AM of procedure

Q24H dosing: Hold dose the AM of procedure

INPATIENT

Q12H and Q24H dosing: Hold enoxaparin dose the AM of

procedure

In the event a Q12H enoxaparin patient is given a dose the

evening before the procedure, you may proceed with

intervention provided the patient is currently an inpatient

AND a radiologist has given approval

fondaparinux (ARIXTRA)CRCL > 50 = Hold for 2 days


heparin

2 hour IV Heparin hold for the University and 4 hour IV

heparin hold for the community sites due to work flow

issues.

"SQ heparin Q8 hrs -- hold for 8 hrs....

SQ heparin Q12 hrs-- hold for 12 hrs.... "

rivaroxaban (XARELTO) 24 hours

warfarin (COUMADIN)

Check with the interventional radiology department on the

hold time for the warfarin.

The hold time length will be based on the INR of the patient

and the discretion of the provider based on the level of the

procedure risk.

IR ProtocolAnticoagulants HOLD

apixaban (ELIQUIS) 48 hours

argatroban (ACOVA) 4 hours

bivalirudin (ANGIOMAX)

CRCL > 50 =


CRCL < 50 =


dabigatran (PRADAXA)

CRCL > 50 = Hold for 3 days


edoxaban (SAVAYSA) 48 hours


OUTPATIENT

Q12H dosing: Hold enoxaparin dose the night before AND the AM

of procedure

Q24H dosing: Hold dose the AM of procedure

INPATIENT

Q12H and Q24H dosing: Hold enoxaparin dose the AM of

procedure

In the event a Q12H enoxaparin patient is given a dose the evening

before the procedure, you may proceed with intervention provided

the patient is currently an inpatient AND a radiologist has given

approval

fondaparinux (ARIXTRA)CRCL > 50 = Hold for 3 days


heparin

2 hour IV hold for the University and 4 hour hold for the community

sites due to work flow issues.

SQ heparin Q8hrs -- hold for 8 hrs....

SQ heparin Q12 hrs-- hold for 12 hrs....

rivaroxaban (XARELTO)CRCL > 30 = 24 hours

CRCL < 30 = 48 hours

warfarin (COUMADIN)

Check with the interventional radiology department on the hold time

for the warfarin (COUMADIN).

The hold time length will be based on the INR of the patient and the

discretion of the provider based on the level of the procedure risk.

Duplicate drug or drug interactions

• Surgical hold protocol

• Best practice alert for procedure order

• Consider failure rates as a potential adverse drug event (ADE)

Pending actions

Questions?

Comments?

75



Vanessa B. Bibbs BSN Accreditation Nurse Specialist Vidant Health

Luba BurmanPharm.D., BCPS,

CDEClinical Assistant Professor, Pharmacy Practice

Chicago State University-

College of Pharmacy

John W. Cromwell MD, FACS,

FASCRS

Associate Chief Medical Officer, Director of Surgical

Quality and Safety; Director, Division of

Gastrointestinal, Minimally Invasive and Bariatric

Surgery Clinical Professor,

University of Iowa Hospitals &

Clinics; University of Iowa

Carver College of Medicine;

Robert M. Dean DO, MBA Senior Vice President, Performance Management Vizient

Tejaswini More

DhawaleMD

Assistant Professor, Division of Hematology

Scholar, Attending Physician,

Platinum/Immunotherapy Service

Center for scholarship in patient

care quality and safety; UWMC

Cheryl EdwardsBS Pharm,

Pharm.D., MBAMedication Safety Manager Parkland Health and Hospital

Ellen FlynnRN, MBA, JD,

CPPSAVP Safety Program Vizient

Rachel Hensley Pharm.D., MBA Directory of Pharmacy SSM Health

Timothy Lesar Pharm.D.Director of Clinical Pharmacy Services, Patient care

Services DirectorAlbany Medical Center

Jim LichauerPharm.D., BCPS,

FASHP

Project Manager, PI Collaborative and Advisory-

Pharmacy Vizient

76






Elena Meeker Pharm.D., BCPS Medication Safety PharmacistUniversity of Washington

Medical Center

Steven B. Meisel Pharm.D., CPPS Director of Patient Safety Fairview Health Services

Joe Melucci RPH, MBA, Medication Safety OfficerThe Ohio State University

Wexner Medical Center

Scott Murray Pharm.D.

Senior Pharmacist, Medication Safety and Pharmacy

Transitions Coordinator, Emergency Department

Pharmacy Manager

Upstate University Hospital

Ketan Patell Pharm.D. DHS-Pharmacy Affairs LA County

Christi Quarles Smith Pharm.D., MBA Assistant director Pharmacy for medication safety University of Arkansas

Jessica Schoenthal RN, MSN, CPPS Collaborative Advisor Vizient Inc.

Robert Sikorski MD

Assistant Professor, Medical Director of Trauma

Anesthesiology, Department of Anesthesiology and

Critical Care Medicine

The Johns Hopkins Hospital

Michelle Then Pharm.D., MBAPharmacy Manager, Medication Safety, Quality &

Regulatory, Denver Health

Syeda WasimaPharm.D., and MPH

Student PSO Intern Vizient Inc.

Tammy Williams RN, MSN, CPPS Collaborative Advisor Vizient Inc.

77




PSO Advisory Teams

Vizient is currently looking for experts to collaborate with Vizient

PSO in the following topics:

• Telemetry alarm fatigue

• Reliable electronic communication among the healthcare team

• Behavioral health management

If you or someone in your organization is an expert and interested

in partnering on these teams, please contact Bobbi Kosloski at

[email protected].




78

mailto:[email protected]

This information is proprietary and highly confidential. Any unauthorized dissemination,

distribution or copying is strictly prohibited. Any violation of this prohibition may be subject

to penalties and recourse under the law. Copyright 2016 Vizient, Inc. All rights reserved.

For additional information, please contact Jessica Schoenthal RN MSN CPPS at

[email protected]

mailto:[email protected]

References

ISMP Quarterly Watch: Perspectives from new adverse event reports available at

http://www.ismp.org/QuarterWatch/pdfs/2016Q2.pdf

Management of Patients on Non–Vitamin K Antagonist Oral Anticoagulants in the Acute Care and Periprocedural Setting:

A Scientific Statement From the American Heart Association available at

http://circ.ahajournals.org/content/early/2017/02/06/CIR.0000000000000477

2017 ACC Expert Consensus Decision Pathway for Periprocedural Management of Anticoagulation in Patients With

Nonvalvular Atrial Fibrillation available at http://www.onlinejacc.org/content/early/2017/01/05/j.jacc.2016.11.024

Burnett, A. E., Mahan, C. E., Vazquez, S. R., Oertel, L. B., Garcia, D. A., & Ansell, J. (2016). Guidance for the practical

management of the direct oral anticoagulants (DOACs) in VTE treatment. Journal of Thrombosis and Thrombolysis, 41,

206–232. http://doi.org/10.1007/s11239-015-1310-7

The ISMP anticoagulation self-assessment is now live at:

http://www.ismp.org/selfassessments/Antithrombotic/2017/Default.aspx

Conway, S.E., Hwang, A.Y., Ponte, C.D., Gums, J.G. (2017). Laboratory and Clinical Monitoring of Direct Acting Oral

Anticoagulants: What Clinicians Need to Know. PHARMACOTHERAPY Vol 37(2).

Michigan Anticoagulation Quality Improvement Initiative Anticoagulation Toolkit (V 1.7): A consortium-Developed Quick

Reference for Anticoagulation. http://anticoagulationtoolkit.org/sites/default/files/toolkit_pdfs/toolkitfull.pdf

UM Medicine Pharmacy Services (2014). http://depts.washington.edu/anticoag/home/content/uw-medicine-alternative-

monitoring-antithrombotic-agents#apixaban




80

http://www.ismp.org/QuarterWatch/pdfs/2016Q2.pdf

http://circ.ahajournals.org/content/early/2017/02/06/CIR.0000000000000477

http://www.onlinejacc.org/content/early/2017/01/05/j.jacc.2016.11.024

http://doi.org/10.1007/s11239-015-1310-7

http://www.ismp.org/selfassessments/Antithrombotic/2017/Default.aspx

http://anticoagulationtoolkit.org/sites/default/files/toolkit_pdfs/toolkitfull.pdf

http://depts.washington.edu/anticoag/home/content/uw-medicine-alternative-monitoring-antithrombotic-agents#apixaban